卡尼汀(肉毒碱)在儿科肠外营养和全营养混合液中的稳定性
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中国临床营养杂志000132Stabitity of carnitine in pediatric TPN and TNA formulations
M. C. Storm ,PhD, B. Wang ,MD ,R. A. Helras ,PharmD
(Department of Clinical Pharmacy, University of Tennessee, Memphis, TN.)
Carnitine is required for transport of long chain fatty acids into the mitocondriarla for oxidation and energy production and is a conditionally essential nutrient in the pediatric patient who requires TPN. Our previous clinical resulls suggest a dally carnitine dosage of 20 mg/kg. However, the stability of carnitine in TPNS and TNAS has not been adequately.
, 百拇医药
Carnitine was added to pediatric TPN and TNA formulations at 130 or 200 mg/L and units were studied on day "zero" or stored at 4～5℃ for 1, 7, 15 or 30 days. Units (including day "zero".) were then mailaied at room temperature (RT) and exposed to constant fluorescent illumination. Units were sampled at 0, 6, 12, 18, and 24 hours. Carnitine concentrations were measured in duplicate by a C-14 radioenzymatic techniqus that is stability indication. Units were also monitored for pH charge, color charge, or observable precipitation.
, 百拇医药
Our results showed no change in pH, no change in color, and no visual precipitation in any of the units, even those stored for 30 days. Zero time recovery of carnitine in six different fromulations was 93. 9 ± 5.3196 (mean ± SD of theoretical, range of 87.8 101%). The results for all periods of storage at 4.5℃ were similar. At 30 days of storage followed by 24 hours at RT, the recovery of carnitine was 93.3 ± 7.30% of theoretical (range of 81.0～102% ). Nether cysteine nor ranitidine appaared to influence the stability of carnitine. A simulated infusion including Y-site addition of 20 % fat emulsion was also performed. Over the course of a 24 hour infusion, samples were obtained at the bag, distal to the in-line 0.22 micron metre, and after mixing with fat emulsion. Recovery of carnitine was 88.1 to 109% of theortical across all sampling sites and time points.
, 百拇医药
Based on this data, we conclude that carnitine is highly stable in TPN and TNA formulations and that no clinically significant loss of carnitine occurs through bag, tubing, or fitler absorption.
长链脂肪酸进入线粒体进行氧化供能时需要卡尼汀参与，他是儿科肠外营养病人的条件必需营养素。根据我们以前的临床研究结果，推荐卡尼汀的剂量为20mg·ke-1·d-1。然而，肠外营养和全营养混合液中卡尼汀的稳定性尚未得以正确评估。
在儿童肠外营养和全营养混合液中以130～200mg/L的标准加以卡尼汀，所配混合液中卡尼汀稳定性的测定时间分别为：配制后的当时和配制后的第1天、第7天、第15天和第30天(此间在4～5℃中保存)。测定后的制剂则置室温保存，并用荧光灯持续照射，分别在0、6、12、18和24小时采取标本。用碳14放射分析技术重复测定同一标本的卡尼汀浓度，这是稳定性的标志。同时检测混合液的pH值变化、颜色变化和可见沉淀物的发生。
, http://www.100md.com
结果表明：保存30天的混合液，没有pH值和颜色的变化，也没有可见沉淀的发生。在配制后当时，6个不同标本的卡尼汀回收率为93.9%±5.31%(理论值的均数±标准差，区间为87.8%～101%)。4～5℃存放的标本，在不同时间点所测定的结果相近。存放30天后，再室温放置24小时，卡尼汀的理论回收率为93.3%±7.30%(区间为81.0%～102%)。半胱氨酸和雷尼替丁都不影响卡尼汀的稳定性。我们进行包括经Y型管输注20%脂肪乳的模拟输液试验，经24小时的输注之后，采集袋中、末梢0.22μm滤器中及与脂肪乳混合后的标本。不同时间点和不同部位标本的卡尼汀回收率是理论值的88.1%～109%。
上述资料提示：卡尼汀在肠外营养和全营养混合液中是高度稳定的，袋子、管于和滤器对卡尼汀的吸收不具有临床意义。, 百拇医药
单位：
关键词：
中国临床营养杂志000132Stabitity of carnitine in pediatric TPN and TNA formulations
M. C. Storm ,PhD, B. Wang ,MD ,R. A. Helras ,PharmD
(Department of Clinical Pharmacy, University of Tennessee, Memphis, TN.)
Carnitine is required for transport of long chain fatty acids into the mitocondriarla for oxidation and energy production and is a conditionally essential nutrient in the pediatric patient who requires TPN. Our previous clinical resulls suggest a dally carnitine dosage of 20 mg/kg. However, the stability of carnitine in TPNS and TNAS has not been adequately.
, 百拇医药
Carnitine was added to pediatric TPN and TNA formulations at 130 or 200 mg/L and units were studied on day "zero" or stored at 4～5℃ for 1, 7, 15 or 30 days. Units (including day "zero".) were then mailaied at room temperature (RT) and exposed to constant fluorescent illumination. Units were sampled at 0, 6, 12, 18, and 24 hours. Carnitine concentrations were measured in duplicate by a C-14 radioenzymatic techniqus that is stability indication. Units were also monitored for pH charge, color charge, or observable precipitation.
, 百拇医药
Our results showed no change in pH, no change in color, and no visual precipitation in any of the units, even those stored for 30 days. Zero time recovery of carnitine in six different fromulations was 93. 9 ± 5.3196 (mean ± SD of theoretical, range of 87.8 101%). The results for all periods of storage at 4.5℃ were similar. At 30 days of storage followed by 24 hours at RT, the recovery of carnitine was 93.3 ± 7.30% of theoretical (range of 81.0～102% ). Nether cysteine nor ranitidine appaared to influence the stability of carnitine. A simulated infusion including Y-site addition of 20 % fat emulsion was also performed. Over the course of a 24 hour infusion, samples were obtained at the bag, distal to the in-line 0.22 micron metre, and after mixing with fat emulsion. Recovery of carnitine was 88.1 to 109% of theortical across all sampling sites and time points.
, 百拇医药
Based on this data, we conclude that carnitine is highly stable in TPN and TNA formulations and that no clinically significant loss of carnitine occurs through bag, tubing, or fitler absorption.
长链脂肪酸进入线粒体进行氧化供能时需要卡尼汀参与，他是儿科肠外营养病人的条件必需营养素。根据我们以前的临床研究结果，推荐卡尼汀的剂量为20mg·ke-1·d-1。然而，肠外营养和全营养混合液中卡尼汀的稳定性尚未得以正确评估。
在儿童肠外营养和全营养混合液中以130～200mg/L的标准加以卡尼汀，所配混合液中卡尼汀稳定性的测定时间分别为：配制后的当时和配制后的第1天、第7天、第15天和第30天(此间在4～5℃中保存)。测定后的制剂则置室温保存，并用荧光灯持续照射，分别在0、6、12、18和24小时采取标本。用碳14放射分析技术重复测定同一标本的卡尼汀浓度，这是稳定性的标志。同时检测混合液的pH值变化、颜色变化和可见沉淀物的发生。
, http://www.100md.com
结果表明：保存30天的混合液，没有pH值和颜色的变化，也没有可见沉淀的发生。在配制后当时，6个不同标本的卡尼汀回收率为93.9%±5.31%(理论值的均数±标准差，区间为87.8%～101%)。4～5℃存放的标本，在不同时间点所测定的结果相近。存放30天后，再室温放置24小时，卡尼汀的理论回收率为93.3%±7.30%(区间为81.0%～102%)。半胱氨酸和雷尼替丁都不影响卡尼汀的稳定性。我们进行包括经Y型管输注20%脂肪乳的模拟输液试验，经24小时的输注之后，采集袋中、末梢0.22μm滤器中及与脂肪乳混合后的标本。不同时间点和不同部位标本的卡尼汀回收率是理论值的88.1%～109%。
上述资料提示：卡尼汀在肠外营养和全营养混合液中是高度稳定的，袋子、管于和滤器对卡尼汀的吸收不具有临床意义。, 百拇医药